Sclerosis, MultiplePhase 2FatSEPNCT03983720
Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?
A Phase 2 study testing Evaluation of degree chronic fatigue., Questionnaires and Blood sample in people with Sclerosis, Multiple, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Chronic fatigue is the most common and debilitating symptom in multiple sclerosis patients. This chronic fatigue affects their quality of life by decreasing their capacity to perform simple tasks of daily life. The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sclerosis, Multiple
- What is being tested?
- Evaluation of degree chronic fatigue., Questionnaires and Blood sample
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2020to 31 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Patients:
- Aged ≥ 18 and ≤ 70 years
- Men or women
- With multiple sclerosis since 2 and 25 years
- Affiliates or beneficiaries of social security scheme
- Signed consent
Show all 10Show fewer
- For Healthy volunteers:
- Aged ≥ 18 and ≤ 70 years
- Men or women
- Matched in accordance with age, sex and level of physical activity
Who cannot join
- For Patients and Healthy volunteers:
- High heart rate resting
- Blood pressure > 144/94 mmHg
- Recent adjustment of drug or drug can have an impact on fatigue or stimulant for fatigue
- Taking neuroactive substances that can alter corticospinal excitability
- Contraindication at application magnetic field
Show all 16Show fewer
- Contraindication at Magnetic Resonance Imaging (MRI)
- Currently participating in a structured exercise program
- Pregnant
- For Patients only:
- Spasticity or cerebellar ataxia
- Abnormal range of motion (toe and/or ankle)
- Musculoskeletal injuries that impedes pedaling
- Appearance of symptoms of multiple sclerosis in the 90 days preceding the study
- For Healthy volunteers:
- Neurological diseases, cardiovascular, musculoskeletal
Trial locations and contacts
1 site in 1 country.
About this study
Chronic fatigue is the most common and debilitating symptom in multiple sclerosis patients. This chronic fatigue affects their quality of life by decreasing their capacity to perform simple tasks of daily life.
The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in this feeling of chronic fatigue. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology will allow to optimize rehabilitation treatments to decrease the apparition/persistence of chronic fatigue and in fine improve quality of life.
- Conditions
- Sclerosis, Multiple
- Being tested
- Evaluation of degree chronic fatigue., Questionnaires, Blood sample, Cardiopulmonary evaluation, Capacity of muscular oxygen extraction
- Keywords
- Sleep assessment, Neuromuscular Fatigability, Multiple sclerosis, Chronic fatigue
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of degree chronic fatigue.Other
Evaluation of degree chronic fatigue with the results of survey Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS). This result will allow to divide patients in groups : lowly fatigued and highly fatigued.
QuestionnairesOther
- Fatigue Severity Scale (FSS)
- Modified Fatigue Impact Scale (MFIS)
- Godin Leisure-Time Exercise Questionnaire (GLTEQ)
- Scale of life quality of multiple sclerosis (SEP-59)
- Center for Epidemiologic Studies Depression (CES-D)
- Pittsburgh Sleep Quality Index (PSQ-I)
Blood sampleBiological
Blood sample will be realized to evaluate anemia and inflammations.
Cardiopulmonary evaluationOther
Cardiopulmonary evaluation will be realized with a cycle ergometer.
Capacity of muscular oxygen extractionDevice
Measure the capacity of muscular oxygen extraction with a cycle ergometer.
Sleep assessmentDevice
Sleep assessment will be measured by actigraphy during 15 days.
Metabolic fatigueDevice
Metabolic fatigue will be measured by Magnetic Resonance Imaging (MRI).
Neuromuscular evaluationOther
Neuromuscular evaluation will be measured by the composite of the results of:
- Fatigue test
- Measure of voluntary isometric force
- Surface electromyography
- Peripheral nerve stimulation
- Transcranial Magnetic Stimulation (TMS)
- Perceived fatigue
- Cognitive fatigue
- Thermoregulation
| Study group | Role | What they receive |
|---|---|---|
| Patient with multiple sclerosis and lowly fatigued | Experimental | Patient with multiple sclerosis and lowly fatigued will be included.
They will have:
Visit 1 (day 0) = Questionnaires, blood sample, cardiopulmonary evaluation, capacity of muscular oxygen extraction, sleep assessment Visit 2 (day 15) = Neuromuscular evaluation Visit 3 (day 30) = Metabolic fatigue Receives: Other: Evaluation of degree chronic fatigue.; Other: Questionnaires; Biological: Blood sample; Other: Cardiopulmonary evaluation; Device: Capacity of muscular oxygen extraction; Device: Sleep assessment; Device: Metabolic fatigue; Other: Neuromuscular evaluation |
| Patient with multiple sclerosis and highly fatigued | Experimental | Patient with multiple sclerosis and highly fatigued will be included. They will have:
Visit 1 (day 0) = Questionnaires, blood sample, cardiopulmonary evaluation, capacity of muscular oxygen extraction, sleep assessment Visit 2 (day 15) = Neuromuscular evaluation Visit 3 (day 30) = Metabolic fatigue Receives: Other: Evaluation of degree chronic fatigue.; Other: Questionnaires; Biological: Blood sample; Other: Cardiopulmonary evaluation; Device: Capacity of muscular oxygen extraction; Device: Sleep assessment; Device: Metabolic fatigue; Other: Neuromuscular evaluation |
| Healthy subjects | Active comparator | Healthy subjects will be included. They will have:
Visit 1 (day 0) = Questionnaires, blood sample, cardiopulmonary evaluation, capacity of muscular oxygen extraction, sleep assessment Visit 2 (day 15) = Neuromuscular evaluation Visit 3 (day 30) = Metabolic fatigue Receives: Other: Questionnaires; Biological: Blood sample; Other: Cardiopulmonary evaluation; Device: Capacity of muscular oxygen extraction; Device: Sleep assessment; Device: Metabolic fatigue; Other: Neuromuscular evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voluntary maximum contraction
Comparison the percentage of decrease in voluntary maximum contraction reported after the fatiguing task. Measured by an instrumented measuring pedal (PowerForce pedal, Model PF1.0.0.0, Radlabor GmbH, Freiburg, Germany)
Measured: Day : 30
Secondary outcomes (12)
Neuromuscular function during the dynamic strenuous exercise
Cortical activity by transcranial magnetic stimulation, evaluated by recording of the evoked motor potentials
.
Measured: Day : 30
Muscle oxygen extraction capacity
Measured by near-infrared spectroscopy (NIRS)
Measured: Day : 30
Anemia
Measured by blood count in blood sample
Measured: Day : 30
Inflammation
Measured by C-reactiv protein in blood sample
Measured: Day : 30
VO2 max
Measured by effort test
Measured: Day : 30
Heart rate
Measured by heart rate monitor
Measured: Day : 30
Cognitive fatigue
Measured by Symbol Digit Modalities Test
Measured: Day : 30
Perceived fatigue
Measured by Borg scale
Measured: Day : 30
Thermoregulation
Measured by digestible thermometric pill (e-celcius Performance)
Measured: Day : 30
Sleep quality
Measured by actigraphy
Measured: Day : 30
Muscle volume
Measured by Magnetic Resonance Imaging
Measured: Day : 30
Metabolic fatigue
Measured by a Phosphorus 31 Nuclear Magnetic Resonance test
Measured: Day : 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start21 Jan 2020
- Primary completion16 Jun 2021
- Study completion31 Jul 2021
Why it stopped: low inclusion rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sclerosis, MultipleStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe CAMDESSANCHE, MD PhD, Principal investigator, CHU DE SAINT ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983720
- Sponsor's protocol ID
- 19CH030
- Other IDs
- 2019-A00427-50
- Acronym
- FatSEP
- Status last verified
- Oct 2023
- First submitted
- 7 Jun 2019
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Fatigability Neuromuscular Explain Chronic Fatigue in People With Multiple Sclerosis?
- ClinicalTrials.gov ID
- NCT03983720
- Acronym / sponsor ID
- FatSEP / 19CH030
- Conditions
- Sclerosis, Multiple
- Keywords
- Sleep assessment, Neuromuscular Fatigability, Multiple sclerosis, Chronic fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low inclusion rates
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic fatigue is the most common and debilitating symptom in multiple sclerosis patients. This chronic fatigue affects their quality of life by decreasing their capacity to perform simple tasks of daily life.
The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in this feeling of chronic fatigue. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology will allow to optimize rehabilitation treatments to decrease the apparition/persistence of chronic fatigue and in fine improve quality of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient with multiple sclerosis and lowly fatigued | Experimental | Other: Evaluation of degree chronic fatigue., Other: Questionnaires, Biological: Blood sample, Other: Cardiopulmonary evaluation, Device: Capacity of muscular oxygen extraction, Device: Sleep assessment, Device: Metabolic fatigue, Other: Neuromuscular evaluationPatient with multiple sclerosis and lowly fatigued will be included. They will have: Visit 1 (day 0) = Questionnaires, blood sample, cardiopulmonary evaluation, capacity of muscular oxygen extraction, sleep assessment Visit 2 (day 15) = Neuromuscular evaluation Visit 3 (day 30) = Metabolic fatigue |
| Patient with multiple sclerosis and highly fatigued | Experimental | Other: Evaluation of degree chronic fatigue., Other: Questionnaires, Biological: Blood sample, Other: Cardiopulmonary evaluation, Device: Capacity of muscular oxygen extraction, Device: Sleep assessment, Device: Metabolic fatigue, Other: Neuromuscular evaluationPatient with multiple sclerosis and highly fatigued will be included. They will have: Visit 1 (day 0) = Questionnaires, blood sample, cardiopulmonary evaluation, capacity of muscular oxygen extraction, sleep assessment Visit 2 (day 15) = Neuromuscular evaluation Visit 3 (day 30) = Metabolic fatigue |
| Healthy subjects | Active comparator | Other: Questionnaires, Biological: Blood sample, Other: Cardiopulmonary evaluation, Device: Capacity of muscular oxygen extraction, Device: Sleep assessment, Device: Metabolic fatigue, Other: Neuromuscular evaluationHealthy subjects will be included. They will have: Visit 1 (day 0) = Questionnaires, blood sample, cardiopulmonary evaluation, capacity of muscular oxygen extraction, sleep assessment Visit 2 (day 15) = Neuromuscular evaluation Visit 3 (day 30) = Metabolic fatigue |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged ≥ 18 and ≤ 70 years
- Men or women
- With multiple sclerosis since 2 and 25 years
- Affiliates or beneficiaries of social security scheme
- Signed consent
Key exclusion criteria (16 listed)
- High heart rate resting
- Blood pressure > 144/94 mmHg
- Recent adjustment of drug or drug can have an impact on fatigue or stimulant for fatigue
- Taking neuroactive substances that can alter corticospinal excitability
- Contraindication at application magnetic field
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of degree chronic fatigue.Evaluation of degree chronic fatigue with the results of survey Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS). This result will allow to divide patients in groups : lowly fatigued and highly fatigued. | Other | Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued |
| Questionnaires* Fatigue Severity Scale (FSS) * Modified Fatigue Impact Scale (MFIS) * Godin Leisure-Time Exercise Questionnaire (GLTEQ) * Scale of life quality of multiple sclerosis (SEP-59) * Center for Epidemiologic Studies Depression (CES-D) * Pittsburgh Sleep Quality Index (PSQ-I) | Other | Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued |
| Blood sampleBlood sample will be realized to evaluate anemia and inflammations. | Biological | Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued |
| Cardiopulmonary evaluationCardiopulmonary evaluation will be realized with a cycle ergometer. | Other | Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued |
| Capacity of muscular oxygen extractionMeasure the capacity of muscular oxygen extraction with a cycle ergometer. | Device | Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued |
| Sleep assessmentSleep assessment will be measured by actigraphy during 15 days. | Device | Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued |
| Metabolic fatigueMetabolic fatigue will be measured by Magnetic Resonance Imaging (MRI). | Device | Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued |
| Neuromuscular evaluationNeuromuscular evaluation will be measured by the composite of the results of: * Fatigue test * Measure of voluntary isometric force * Surface electromyography * Peripheral nerve stimulation * Transcranial Magnetic Stimulation (TMS) * Perceived fatigue * Cognitive fatigue * Thermoregulation | Other | Healthy subjects, Patient with multiple sclerosis and highly fatigued, Patient with multiple sclerosis and lowly fatigued |
Primary outcome
Voluntary maximum contraction
Time frame: Day : 30
Comparison the percentage of decrease in voluntary maximum contraction reported after the fatiguing task. Measured by an instrumented measuring pedal (PowerForce pedal, Model PF1.0.0.0, Radlabor GmbH, Freiburg, Germany)
12 secondary outcomes
Neuromuscular function during the dynamic strenuous exercise
Time frame: Day : 30
Muscle oxygen extraction capacity
Time frame: Day : 30
Anemia
Time frame: Day : 30
Inflammation
Time frame: Day : 30
VO2 max
Time frame: Day : 30
Heart rate
Time frame: Day : 30
Cognitive fatigue
Time frame: Day : 30
Perceived fatigue
Time frame: Day : 30
Thermoregulation
Time frame: Day : 30
Sleep quality
Time frame: Day : 30
Muscle volume
Time frame: Day : 30
Metabolic fatigue
Time frame: Day : 30
Results and safety
The study was stopped early (reason given: low inclusion rates). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe CAMDESSANCHE, MD PhD principal investigator
CHU DE SAINT ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Evaluation of degree chronic fatigue., Questionnaires and Blood sample in people with Sclerosis, Multiple, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low inclusion rates). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voluntary maximum contraction (time frame: Day : 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.